bortezomib in treating patients with mantle cell lymphoma

Conditions: Lymphoma

Summary: rationale: bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. purpose: phase ii trial to study the effectiveness of bortezomib in treating patients who have previously untreated or relapsed mantle cell lymphoma.

objectives: * determine the efficacy of bortezomib, in terms of response rate, in patients with previously untreated or relapsed mantle cell lymphoma. * determine the toxicity of this drug in these patients. * correlate suppression of 20s proteasome levels with toxicity of and response to this drug in these patients. * determine the time to progression and response duration in patients treated with this drug. outline: this is a nonrandomized, multicenter study. patients receive bortezomib iv over 3-5 seconds on days 1, 4, 8, and 11. courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. patients with complete response (cr) receive 2 courses beyond documentation of cr. patients with stable disease receive a maximum of 4 courses. patients with partial response (pr) continue therapy until disease progression or for 2 courses beyond documentation of stable pr. patients are followed at 4 weeks and then every 3 months until disease progression. projected accrual: a total of 14-30 patients will be accrued for this study within 18-24 months.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed relapsed or untreated mantle cell lymphoma * no refractory disease defined as progression while on chemotherapy or within 1 month after completion of chemotherapy * at least 1 bidimensionally measurable disease site\* * lymph nodes at least 1.5 cm by 1.5 cm by spiral ct scan or * non-nodal lesions (e.g., skin lesion or nodules) at least 1 cm by 1 cm by mri, ct scan, or physical exam note: \*bone lesions are not considered bidimensionally measurable disease * no pre-existing ascites or pleural effusion * no known cns involvement by lymphoma patient characteristics: age: * 18 and over performance status: * ecog 0-2 life expectancy: * at least 12 weeks hematopoietic: * absolute granulocyte count at least 1,500/mm\^3 * platelet count at least 75,000/mm\^3 hepatic: * bilirubin no greater than 1.5 times upper limit of normal (uln) * ast or alt no greater than 2.5 times uln renal: * creatinine no greater than 1.5 times uln cardiovascular * lvef at least 45% by echocardiogram or muga pulmonary * no pre-existing shortness of breath greater than grade 1 other: * no uncontrolled bacterial, fungal, or viral infections * no pre-existing edema greater than grade 1 * no pre-existing neuropathy greater than grade 1 * no other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix * no other serious illness or medical condition that would preclude study compliance * no geographical conditions that would preclude study compliance * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * see chemotherapy * prior rituximab allowed * no prior radioactive monoclonal antibody therapy chemotherapy: * see disease characteristics * no prior high-dose chemotherapy with stem cell transplantation * no more than 2 prior systemic chemotherapy regimens * same chemotherapy combination given for first-line and second-line therapy is considered 2 regimens * no prior flavopiridol * at least 6 weeks since prior chemotherapy * no concurrent cytotoxic chemotherapy endocrine therapy: * no concurrent corticosteroids radiotherapy: * no prior radiotherapy to 25% or more of functioning bone marrow * at least 4 weeks since prior radiotherapy (except low-dose nonmyelosuppressive radiotherapy) and recovered * no concurrent radiotherapy to the sole site of measurable disease surgery: * at least 2 weeks since prior major surgery other: * no prior investigational therapy * no other concurrent anticancer therapy * no other concurrent investigational anticancer therapy

Keywords: stage i mantle cell lymphoma contiguous stage ii mantle cell lymphoma noncontiguous stage ii mantle cell lymphoma stage iii mantle cell lymphoma stage iv mantle cell lymphoma recurrent mantle cell lymphoma